Luo Fan, Zhang Zhonghan, Liao Kunlun, Zhang Yang, Ma Yuxiang, Hu Zhihuang, Zeng Kangmei, Huang Yan, Zhang Li, Zhao Hongyun
Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou 510060, China.
Department of Outpatient, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou 510060, China.
Ann Transl Med. 2019 Jun;7(12):253. doi: 10.21037/atm.2019.04.65.
Chemotherapy with targeted therapy is a promising therapeutic option for advanced non-small cell lung cancer (NSCLC) patients. Response Evaluation Criteria in Solid Tumors (RECIST) criteria were used in tumor response evaluation. We assumed an optimal threshold for this therapeutic setting and tried to seek a new tumor shrinkage cutoff with the data from five clinical trials in one institution.
The X-tile program was used to identify the optimal cut-off value of tumor shrinkage. PFS and OS were compared in the current study. Kaplan-Meier method was used to describe PFS and OS. 95% CI was calculated for PFS and OS outcomes to assess the treatment efficacy. A P value of less than 0.05 was considered statistically significant. SPSS 23.0 was used for all statistical analysis.
X-tile analysis yielded -10% in the ∆SLD of the target lesions as the optimal threshold for response/non-response. The 10% tumor shrinkage could discriminate responders from non-responders in PFS (10.1 2.50 months, P=0.0007) and OS (23.00 7.66 months, P<0.0001). Univariate and multivariable analysis showed that 10% tumor shrinkage was a valid prognostic factor for PFS (P=0.018) and OS outcome (P<0.0001).
A 10.0% tumor shrinkage in the SLD indicated an indicative efficacy evaluation threshold for NSCLC patients treated with chemotherapy plus targeted agents.
化疗联合靶向治疗是晚期非小细胞肺癌（NSCLC）患者一种有前景的治疗选择。实体瘤疗效评价标准（RECIST）用于评估肿瘤反应。我们假设了这种治疗方案的最佳阈值，并试图利用一家机构五项临床试验的数据寻找新的肿瘤缩小临界值。
使用X-tile程序确定肿瘤缩小的最佳临界值。在本研究中比较了无进展生存期（PFS）和总生存期（OS）。采用Kaplan-Meier法描述PFS和OS。计算PFS和OS结果的95%置信区间（CI）以评估治疗效果。P值小于0.05被认为具有统计学意义。所有统计分析均使用SPSS 23.0。
X-tile分析得出，目标病灶的实体瘤最长径总和（∆SLD）缩小10%为反应/无反应的最佳阈值。10%的肿瘤缩小可在PFS（10.1±2.50个月，P=0.0007）和OS（23.00±7.66个月，P<0.0001）方面区分反应者和无反应者。单因素和多因素分析表明，10%的肿瘤缩小是PFS（P=0.018）和OS结果（P<0.0001）的有效预后因素。
实体瘤最长径总和缩小10.0%表明是接受化疗加靶向药物治疗的NSCLC患者疗效评估的一个指示性阈值。
